naloxone and Spinal-Diseases

A prolonged-release formulation of oxycodone/naloxone has been shown to be effective in European populations for the management of chronic moderate to severe pain. However, no clinical data exist for its use in Korean patients. The objective of this study was to assess efficacy and safety of prolonged-release oxycodone/naloxone in Korean patients for management of chronic moderate-to-severe pain.. In this multicenter, single-arm, open-label, phase IV study, Korean adults with moderate-to-severe spinal disorder-related pain that was not satisfactorily controlled with weak opioids and nonsteroidal anti-inflammatory drugs received prolonged-release oral oxycodone/naloxone at a starting dose of 10/5 mg/day (maximum 80/40 mg/day) for 8 weeks. Changes in pain intensity and quality of life (QoL) were measured using a numeric rating scale (NRS, 0-10) and the Korean-language EuroQol-five dimensions questionnaire, respectively.. Among 209 patients assessed for efficacy, the mean NRS pain score was reduced by 25.9% between baseline and week 8 of treatment (. Prolonged-release oxycodone/naloxone provided significant and clinically relevant reductions in pain intensity and improved QoL in Korean patients with chronic spinal disorders. (ClinicalTrials.gov identifier: NCT01811238).

Topics: Aged; Analgesics, Opioid; Back Pain; Chronic Pain; Constipation; Delayed-Action Preparations; Dizziness; Drug Combinations; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Naloxone; Nausea; Oxycodone; Pain Measurement; Quality of Life; Republic of Korea; Severity of Illness Index; Spinal Diseases

Topics: Humans; Naloxone; Nervous System Diseases; Pruritus; Spinal Diseases

To identify spine patients' barriers to appropriate postoperative opioid use, comfort with naloxone, knowledge of safe opioid disposal practices, and associated factors.. We preoperatively surveyed 174 spine patients about psychobehavioral barriers to appropriate opioid use, comfort with naloxone, and knowledge about opioid disposal. Multivariable logistic regression identified factors associated with barriers and knowledge (α = 0.05).. Common barriers were fear of addiction (71%) and concern about disease progression (43%). Most patients (78%) had neutral/low confidence in the ability of nonopioid medications to control pain; most (57%) felt neutral or uncomfortable with using naloxone; and most (86%) were familiar with safe disposal. Anxiety was associated with fear of distracting the physician (adjusted odds ratio [aOR], 3.8; 95% confidence interval [CI], 1.1-14) and with lower odds of knowing safe disposal methods (aOR, 0.18; 95% CI, 0.04-0.72). Opioid use during the preceding month was associated with comfort with naloxone (aOR, 4.9; 95% CI, 2.1-12). Patients with a higher educational level had lower odds of reporting fear of distracting the physician (aOR, 0.30; 95% CI, 0.09-0.97), and those with previous postoperative opioid use had lower odds of concern about disease progression (aOR, 0.25; 95% CI, 0.09-0.63) and with a belief in tolerating pain (aOR, 0.34; 95% CI, 0.12-0.95).. Many spine patients report barriers to appropriate postoperative opioid use and are neutral or uncomfortable with naloxone. Some are unfamiliar with safe disposal. Associated factors include anxiety, lack of recent opioid use, and no previous postoperative use.

Topics: Adult; Aged; Analgesics, Opioid; Female; Health Knowledge, Attitudes, Practice; Humans; Male; Middle Aged; Naloxone; Narcotic Antagonists; Pain, Postoperative; Spinal Diseases